|Publication number||US7288076 B2|
|Application number||US 10/371,018|
|Publication date||Oct 30, 2007|
|Filing date||Feb 21, 2003|
|Priority date||Aug 29, 1996|
|Also published as||US20030171703|
|Publication number||10371018, 371018, US 7288076 B2, US 7288076B2, US-B2-7288076, US7288076 B2, US7288076B2|
|Inventors||Tracy Grim, William K. Arnold, Joseph M. Iglesias|
|Original Assignee||Ossur Hf|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (12), Referenced by (63), Classifications (6), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation-in-part of U.S. application Ser. No. 09/857,396, filed May 31, 2001, now U.S. Pat. No. 7,018,351, which is a national phase entry of international application no. PCT/US97/15265, filed internationally on Aug. 29, 1997, which is a continuation-in-part of U.S. application Ser. No. 08/705,218, filed Aug. 29, 1996, now abandoned, all of whose contents are hereby incorporated by reference.
The present invention generally relates to an improved orthopedic device, and specifically to a orthopedic support for body limbs or joints with emphasis on the construction of the support for comfort fit.
U.S. Pat. No. 5,125,400 discloses an ankle brace having sidewall members with inflatable air cells. One air cell is the same length as its corresponding sidewall member, while a second air cell is shorter. The air cells are arranged in an overlapping manner.
U.S. Pat. No. 5,496,262 discloses a brace having a pressure source that provides intermittent pressure pulses to fluid that fills inflatable chambers. The brace has fluid exhaust means that continuously exhausts the fluid from the inflatable chambers to atmosphere.
One specific, non limiting embodiment of the invention is an ankle brace having first and second semi-rigid shell members for extending over the ankle and the lower leg on the inner and outer sides of the ankle, and a sealed bladder pad mounted to each of the shell members on the side of the shell member facing the ankle. It should be noted that a semi-rigid shell member is desired; however, in some embodiments that shell member may be more or less rigid. Each bladder pad includes interconnected bladders on the pad. In one particular embodiment, there are three such bladders formed on the pad. In this embodiment, a first larger bladder is mounted at the lower end of the shell, and two side-by-side upper bladders are mounted on an upper portion of the associated shell member. The three bladders have restricted openings permitting limited flow of air between at least some of the bladders. When a patient wearing the ankle brace walks, the lower bladder is compressed, and air is directed through the restricted openings to the upper bladders, thereby intermittently varying the pressure on the ankle and lower leg, and promoting circulation.
Another specific embodiment is an ankle brace having first and second semi-rigid shell members for extending over the ankle and the lower leg on the inner and outer sides of the ankle. Onto each of the shell members on the side of the shell member facing the ankle, there is mounted a respective bladder pad. Each bladder pad includes three small interconnected bladders wherein a first larger bladder is mounted at the lower end of the shell, and two side-by-side upper bladders are mounted on an upper portion of the associated shell member; the three bladders having restricted openings permitting limited flow of air between the bladders; and resilient cushioning material mounted to each the shell and the bladders on the side of the shell facing the ankle; whereby when a patient wearing the ankle walks, the lower bladder is compressed, and air is directed through the restricted openings to the upper bladders, thereby intermittently varying the pressure on the ankle and lower leg, and promoting circulation.
Optional aspects of the invention include one or more special features. The cushioning material may be a thin layer of resilient material substantially coextensive with each the bladder. The cushioning material may be a plastic sheet with geometric shapes thereon extending outward from the plastic sheet, toward the shell. The resilient material may be loop type padding material, and the hook type material may be bonded to the shells for hook and loop type mounting of the resilient material to the shells.
Considering another embodiment, an ankle brace has first and second semi-rigid shell members for extending over the ankle and the lower leg on the inner and outer sides of the ankle. A sealed bladder pad is mounted to each of the shell members on the side of the shell member facing the ankle. Each bladder pad includes a plurality of interconnected bladders. At least two of the bladders have restricted openings permitting limited flow of air between the at least two bladders. A resilient pad has resilient geometric shapes thereon extending toward the shell, and is bonded to said shell covering said bladder around the periphery of the shell.
Considering other possible aspects, the resilient geometric shapes are in the lower half of the resilient pad. The geometric shapes may be ellipses. An overmold may substantially surround the shell and the pad may be bonded to the overmold, substantially sealing together the orthopedic support. The ankle brace may further comprise means for securing the ankle support around the lower leg. The pad may further comprise a plurality of integrally molded fingers and/or other shapes extending from the pad to the outer shell. These shapes may be integrally molded with the pad, or as separate molded structures. Some of the fingers may have a different length than others of the fingers. The pad may be formed of a thermoplastic elastomer (TPE).
It should be noted that specific embodiments of the invention may include the bladder pad, but not the cell pad. A layer of padding material other than a cell pad may be interposed in between the bladder pad and the skin of the user. Or, in some embodiments, the bladder pad may be placed directly on the skin of the user.
Other aspects, features, and advantages of the present invention will be apparent to those persons having ordinary skill in the art to which the present invention relates from the foregoing description and the accompanying drawings.
Referring to the drawings, particularly to
The comfortable ankle support may be secured onto the lower leg using fastening fabric, such as the hook and loop type fastening material sold under the trade name VELCROŽ, straps and buckles, or any other suitable means.
Although the preferred embodiment of the present invention as disclosed as being implemented using a pair of rigid side supports, the pad 110 may be used as the cushioning member for a unitary ankle support such as the “Adjustable Tension Ankle Support” disclosed by U.S. Pat. No. 4,869,267 issued to Tracy E. Grim and Thomas M. Smario.
The rigid outer support, or the shell, 112 a may be formed of relatively stiff or semi-rigid plastic, and may include cutouts 144 and 146 which serve to increase the shell's flexibility near the malleolus area 145 to increase the comfort and to decrease the chance of the shell 112 a digging into the often sensitive ankle region. The cutouts 144, 146 may be implemented on any portion of the shell 112 a to increase the flexibility of the shell 112 a for the area. A receptacle 148 is provided near the bottom of the shell 112 a to allow the attachment of the heel strap 128 of
The liner 140 a of the ankle support is substantially smooth. The overmold 108 a as utilized substantially covers at least the outer edges of the TPE pad 110 a, the liner 140 a, and the shell 112 a forming an air-tight seal and trapping air.
Again, if the pad 110 a is welded or bonded onto the shell 112 a and if the pad 110 a includes a substantially continuous surface (for the side away from the shell), then the liner 140 a and the overmold 108 a are not necessary elements of the ankle support.
In the embodiment as shown by
In an alternative embodiment, the shell itself includes the overmold about its edges. A pad is molded separately, and the edge of the pad is bonded to the overmold The liner 140 a would either be molded with the lip, or would be a separate material onto which the lip 108 a is molded.
The utilization of the injection molded TPE material for orthopedic supports has many advantages. First, the TPE pad can be molded to include detailed designs such as geometrically shaped cells. The TPE pad can be specifically contoured to the malleolus areas, the calf, and the calcaneal regions of the support. Although the TPE material is more dense than other padding materials such as foam, the innovative design including molded cell-structure as illustrated by
One suitable thermoplastic elastomer (TPE), is available under the name RIMFLEX, made from KRATONŽ Polymer. It is produced by Shell Oil Company and is available from Synthetic Rubber Technologies of Uniontown, Ohio. There are many other sources of thermoplastic elastomers. The material may be molded by any of the numerous injection-molding companies across the nation. Other material may be used in place of the TPE, including thermosetting and thermoplastic materials.
Continuing to refer to
Referring now to
Alternatively, instead of a bladder 172, the additional cushioning may be provided by inserting other soft material in the space such as open cell foam material or gels.
Reference number 117 shows that the structures for the pad 110 may be formed such that the TPE material does not span the entire distance from the liner 140 to the shell 112 creating a pressure free travel of the padding 110 to the shell 112. The pressure free travel design provides for unsurpassed softness and comfort for the area of the pad. This technique allows additional air to be trapped under the pad 110 and creates additional room for the pad 110 to flex for softer cushioning. Also, the reduction in the amount of material used for the pad 110 leads to a lighter ankle support and reduced production costs.
An alternative embodiment of the ankle support is illustrated by
In the embodiment of the present invention as illustrated by
Utilizing the geometrically shaped cells molded onto the TPE pad, the ankle supports 102, 104 of
An alternative embodiment of the orthopedic support 200 is illustrated by
Also illustrated by
The shell 112 d of the ankle support 202, 204 may be formed to surround but not cover the malleolus area 114 d, with the trampoline cushioning effect resulting from the lack of rigid coverage in the malleolus area allowing less padding in that area.
Alternatively, for the cross section of the ankle support as illustrated by
The arrangement of
In the preferred embodiment that
Yet another alternative embodiment of the ankle support is illustrated by
Another alternative embodiment of the orthopedic support of the present invention is illustrated by
The aspect ratio of the fingers 321 are varied to provide more or less cushioning in particular regions of the support. For example,
The fingers 321(a)(b) also serve to space the flexible inner portion of the support from the hard outer portion of the support. Consequently, the longer fingers 321 a provide additional space between the malleous of the ankle and the hard outer shell 312 of the brace. The malleolar region of the ankle is typically where the ankle is injured, and the injury may be exacerbated if the injured portion of the ankle hits the hard outer shell of the support. The longer fingers prevent the malleous from hitting the hard outer shell during use, and provide softer cushioning which makes the brace more comfortable for the wearer during healing.
It should be noted that the outer shell 312 in
Additional air holes 355 may be included in the pad 310 itself. For example, the pad 310 in
As an additional alternative, the thickness of the pad walls may vary in different regions of the pad. For example, the wall thickness of the pad of
A pad having varying skin thickness is preferably formed by injection molding. However, other methods in which a liquid material solidifies to form to the shape of the mold, such as (for example) reaction-injection molding or pour molding may be employed. To vary the thickness of the skin of the pad while at the same time forming a pad cell structure and integral fingers generally requires a manufacturing method in which a liquid material fills a cavity defining the desired pad configuration, then solidifying to conform the shape of the pad to the shape of the cavity.
Referring in particular to
In the presently preferred embodiment, the pad 310 bonds only to the overmold 308 to secure the pad to the shell. The pad is typically bonded to the overmold with a conventional solvent that melts material on both the edge 310 a of the pad and on the overmold. The melted material then solidifies to form the bond. However, the pad may be bonded to the overmold in other ways, such as by welding or with adhesives. In alternative embodiments, the pad may be adhered directly to the shell.
In the preferred embodiment of the present invention as illustrated by
Although the present invention has been described in detail with regarding the exemplary embodiments and drawings thereof and with regarding alternate embodiments, it should be apparent to those skilled in the art that various adaptations and modifications of the present invention may be accomplished without departing from the spirit and the scope of the invention. Thus, by way of example and not of limitation, the present invention has been described as an ankle support. However, it is apparent that the inventive support may be applied to arms, legs, and other part of the body requiring varying degrees of localized comfort. Incidentally, where reference is made hereto to air cells or geometric cells, reference is to macro-cells with dimensions greater than 1/64 or 1/32 of an inch for example, and not to foams. Accordingly, the invention is not limited to the precise embodiment shown in the drawings and described in detail hereinabove.
Pads according to some of the embodiments of the present invention may be sealed, such that a space is formed between the pad and the shell that can be filled with air or other fluid to form a fluid bladder. The shell may include an air pump with which the user can inflate the bladder. A release valve can be provided permitting the user to release air from the bladder as necessary.
It should be noted that the cell structure described in connection with the present invention has additional applications. For example, open cells can be inserted in between two layers of material which together form a bladder. The cells act as reinforcement to the bladder, such that if the bladder deflates or if an especially great load is applied to the bladder, the cell structure reduce the likelihood that the bladder will bottom out.
While a pad made with a TPE material has been described, and while the inventors presently prefer to make the pad from TPE material, it should be understood that the pad may be made from a variety of other materials. For example (but without limitation) the pad may be made of thermoplastic urethanes, thermoplastic rubbers, silicones, two-part urethane mixtures and poured foams.
It should be noted that the fingers 321 are shown in the figures as having a generally circular cross-section. However, the fingers can have various other cross-sections, so long as they perform a cushioning function.
While the pads described herein are particularly well suited for use in orthopedic supports, there are numerous other applications in which such pads could be employed. For example, embodiments of this type of pad may be employed in various protective devices, such as kneepads, shin guards, and football pads, among other applications where durability and water resistance is desired.
Considering now a further alternative embodiment illustrated in
An outer pad 1000 with cells 1002 provides support and helps to protect the bladder from puncture by foreign objects. The pad 1000 also provides additional cushioning to help ensure that the bone or the skin is protected from contacting the shells during impact. In the embodiment illustrated, the cells 1002 are generally contained within an ovular area 1004 in the bottom portion of the pad corresponding to the malleolus of the ankle. In the illustrated embodiment, the cells are ovular in shape, although other shapes may be employed.
Alternative embodiments may have more or fewer bladders. The preferred embodiment of the air bladder has restricted openings 1024 and 1026 from the bottom bladder to the top two bladders. As pressure is applied to the bottom bladder, the air transfers to the top two, but it transfers at a slower rate than if the openings were not restricted. The rate of air transfer can be adjusted by opening or narrowing that gap, or lengthening or shortening it.
The restricted openings 1024, 1026 and 1028, and the resulting controlled movement of air provide a unique “feel” to the ankle brace. The transfer of air through the restricted openings provides a more fluid, somewhat gel-like feel when pressure from the ankle is applied. Generally, the restricted openings slow the air transfer process, as compared to a bladder having no airflow restrictions. The air transfer reduces the likelihood that the pad will bottom out upon pushing down on it. Once the pressure is taken off the bladder, the air pressure equalizes itself among the bladders that are connected to one another.
In the preferred embodiment, the bladder is filled only with air, and is not filled with foam, for example. However, in alternative embodiments, the bladder may be filled with gases other than or in addition to air, and/or may include foam or other filler material. In particular embodiments, a restricted opening 1028 between the top two bladders may be formed, although this is not required.
The bladder pad 1006 may be made of welded sheets of vinyl film, or urethane, or any other film that will hold air. The welding is typically RF welding, although other types of welding known in the art may be used. One method of welding is discussed in U.S. Pat. No. 5,026,389, which is incorporated by reference herein. The bladder pad 1006 may be attached to the shell by way of adhesive, such as double sided tape or spray adhesive.
In the embodiment illustrated, the top portion of the bladder pad has two smaller bladders separated by a “dart,” or weld line. With two smaller bladders as opposed to a single large bladder, the bladder is less likely to bottom out. The dart serves to limit the expansion of each smaller bladder, there by reducing the overall thickness of the bladder when pressurized. Specific darting patterns can be utilized to create different shapes and thickness pads, depending on the requirements of the specific application.
Concerning the size of the openings, the size of the opening determines the amount of air and the speed in which the air is transferred from one area of the bladder to another. In one embodiment, the restricted openings are 0.125″ wide. The top two bladders have a width of approximately 1.5″ each. The bottom bladder, at its widest point, measures 2.5″ wide, and 1.0″ at the narrowest, in one embodiment.
As described previously, the cell pad has cell walls that collapse under pressure. This effectively works to provide additional cushioning for the brace.
Considering now the embodiment of
In addition to the embodiment shown in
These alternative embodiments may make use of the overmold and pivoting heel strap, as desired. The bladder concept is not limited to ankle braces, but may be extended to other types of orthopedic supports, such as wrist braces and knee supports. Wrist braces and knee supports are known in the art. A multiple bladder pad may be added to the layers of material in existing wrist braces or knee supports, or may be added in place of an existing layer in a prior art structure.
From the foregoing detailed description, it will be evident that there are a number of changes, adaptations, and modifications of the present invention which come within the province of those skilled in the art. However, it is intended that all such variations not departing from the spirit of the invention be considered as within the scope thereof as limited solely by the claims appended hereto. It is therefore intended that the following claims may be interpreted as covering all such applications, alterations and modifications as fall within the true spirit and scope of the invention.
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|U.S. Classification||602/5, 602/27|
|International Classification||A61F5/00, A61F5/01|
|May 16, 2003||AS||Assignment|
Owner name: ROYCE MEDICAL PRODUCTS, CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GRIM, TRACY;ARNOLD, WILLIAM K.;IGLESIAS, JOSEPH M.;REEL/FRAME:014080/0764;SIGNING DATES FROM 20030228 TO 20030313
|Sep 29, 2005||AS||Assignment|
Owner name: KAUPTHING BANK HF, NEW YORK
Free format text: SECURITY AGREEMENT;ASSIGNOR:ROYCE MEDICAL COMPANY;REEL/FRAME:016610/0376
Effective date: 20050901
|Mar 16, 2007||AS||Assignment|
Owner name: OSSUR HF, ICELAND
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:ROYCE MEDICAL COMPANY;REEL/FRAME:019028/0284
Effective date: 20070308
|Apr 15, 2011||FPAY||Fee payment|
Year of fee payment: 4
|Apr 15, 2015||FPAY||Fee payment|
Year of fee payment: 8